MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
Status:
Not yet recruiting
Trial end date:
2027-01-01
Target enrollment:
Participant gender:
Summary
Postoperative agitation and emergence delirium describe a spectrum of symptoms of early
postoperative negative behavior, in which the child experiences a variety of behavioral
disturbances including crying, thrashing, and disorientation during early awakening from
anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some
clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk
of emergence agitation in children, some finding a considerable dose-response effect.
Melatonin has a low bio-availability of approximately 15 %. The safety of exogenous melatonin
for pediatric patients has been studied with no apparent serious adverse effects, even at
repeated short-term use of high doses of intravenous melatonin. The aim of this clinical
trial is to investigate the prophylactic effects and safety of intravenous melatonin
administered intraoperatively for prevention of postopreative agitation and emergence
delirium in children after an elective surgical procedure. The study is designed as a
randomised, double-blind, placebo-controlled clinical trial.
Phase:
Phase 3
Details
Lead Sponsor:
Rigshospitalet, Denmark
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research Sygehus Lillebaelt University of Copenhagen